I live in Scotland in the UK, and about 6 weeks ago started on the Phase2 trial for a Japanese drug, a tyrone kinase inhibitor, made by Shiniogi.

I had extensive mets in my lungs, trouble breathing and coughing a lot. Within 3 or 4 days I noticed I was coughing less - 6 weeks on I feel great. No cough, breathing well, bags more energy. I get a scan soon so will know exactly what the response has been.

I believe it has also shown efficacy on brain mets, and another lady in our small group on the trial here has had significant reduction in her brain mets.

I genuinely feel this is a wonder drug (I had previously not responded to Xeloda/Capcetibine OR to TDM-1/Kadcyla, so was fast running out of options). From what I can gather, it has had a really good success rate. Out of us 10 patients, 9 responded.

And even better, there are very few and fairly minor side effects. I have had almost none. Anyone on the trial elsewhere, or know anything about it?

I contacted the lead researcher in this trial, and for now they have no plans for a phase II of this trial. I also contacted the Japanese company headquartered in New Jersey, and expressed interest in participating in a Phase II of this trial, should it get that far.

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Breastfeeding when diagnosed with Her2+ May 2008
Oct 2008 Double mastectomy 22/28 lymph nodes positive
Decline chemotherapy (decision I regret)
Nov 2009 Mets to lungs and bones.
Dec 2009 Start Taxotere and Herceptin, T1, T3 heal completely and lungs are clear, T2 and first rib have lytic lesions. First rib becomes sclerotic. Considered stable.
May 2011, Onc calls progression and I cross over from comparison arm of clinical trial to TDM-1
Brain scan in Sept 2011 showed small tumor in right cerebellum, did Novalis radiation.

Feb 2013 < 1cm tumor in left frontal lobe. Did Novalis in March and latest scan shows no sign of brain metastasis.
Aug 2013 did 36th round of TDM-1 Due to TDM-1 side effects, shortness of breath, and difficulty getting my balance when getting out of bed, agreed with my oncologist to stop TDM-1.
Took a six week break, bone scan showed small uptake on left first rib. CT showed hypodensities in liver (too small to biopsy) and small nodule in lungs (mediastinal).
Started Navelbine weekly. Did one round with Herceptin.
Skipped next 2 rounds, due to neutropenia. Next chemo 7th Nov - have had 3 Neupogen shots, so WBC should look better... Did not tolerate Navelbine well.
December 2013 scans show no sign of active cancer.
March 2014 - currently only on Herceptin - brain MRI clear, PET/CT two nodules in right lung show uptake
May 2014 - stop Herceptin.
Sept 22, 2014 Brain MRI clear :) PET/CT Progression in lungs.
Sept 2014, Xeloda, Tykerb and Herceptin.
Nov 2014 - Decide to take a break from all treatment.
May 2015 - Brain met radiated with Novalis
July 2015 - Have progression in right lung.
Sept 2015 - Perjeta and Herceptin alone after a 9 month break from all treatment.
Nov 2015 - Thoracentesis 1500ml removed from right lung.
Dec 2015 - Two tiny 1mm brain mets radiated in right cerebellum.
Feb 2016 - Thoracentesis 2200ml drained from right lung
Feb 2016 - Stopped Perjeta and Herceptin and started back on Kadcyla as I had no previous progression on it. After 1 cycle of Kadcyla markers begin to drop. On second cycle add Keytruda.
March 2016 - Thoracentesis 1650ml drained from right lung.
April 2016 – Thoracentesis 1500 ml drained from right lung.
June 2016 – CT scan shows progression in right lung, as well as moderate pleural effusion requiring Thoracentesis.
June 2016 – Decide to stop Keytruda, and will do chemosensitivity test through Rational Therapeutics. Plan to continue on Kadcyla for next two cycles.
July 2016 - Start weekly Abraxane with Herceptin. WBRT with hippocampal sparing, Taking Namenda. 15 sessions over 3 weeks.
Aug - Dec 2016 - 2 infusions of Navelbine, very hard on my body and still dealing with anasarca (generalized edema) 1 infusion of Havalen
My doctor wants to put me on hospice.
Dec 23rd 2016 - I am granted compassionate use of Neratanib.
May 31st 2017 - still on Neratinib, feeling good.

I asked when I was last in hospital what will happen with this drug, as its been very successful in our small cohort of women - 10 out of 11 responded, at least one complete remission and everyone else good partial responses. Its a phase1/2 I think. Was told they will collect all the data this year and decide whether to take forward - I am praying that they do asap as it is fantastic, and almost no side effects as so targeted.

I had previously filed on Xeloda, kadcyla and Herceptin hadn't really worked either, so things weren't looking good.

If I hear any more will let you know

Best wishes and hope things stay stable . Let me know if you get on MM302 and how that is, as Im always looking for the next drug.